BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    CARDIA INNOVATION AB

    Reg #: 3005555621 · FEI: 3005555621 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CARDIA INNOVATION AB
    Registration Number
    3005555621
    FEI Number
    3005555621
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Gustavslundsvaegen 143
    City
    Bromma Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K112975

    Owner / Operator

    Firm Name
    CARDIA INNOVATION AB
    Operator Number
    9076128
    Address
    Gustavslundsvaegen 143, --
    City
    Bromma
    State
    Stockholm
    Postal Code
    SE-167 51
    Country
    SE
    Correspondent
    Sebastian Bauer

    US Agent

    Business Name
    Pro Pharma Group
    Contact Name
    Cherita James
    Address
    1129 20th St Nw Ste 600
    City
    Washington
    State
    DC
    ZIP
    20036
    Country
    US
    Email
    [email protected]
    Phone
    347 9540624

    Products

    Device Name Product Code
    Insufflator, Laparoscopic HIF

    Proprietary Names

    CarbonAid, CarbonMini

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility